Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Notification: Hikma Farmacêutica, Gemcitabine 2g/52.6ml concentrate for solution for infusion |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effects of serious skin reactions.
Gemcitabine 2g/52.6ml concentrate for solution for infusion is administered by Healthcare Professionals within a hospital setting, and most healthcare professionals will already be aware of these serious skin reactions.
The missing information is:
PIL Section 2
Talk to your doctor, nurse or hospital pharmacist before using gemcitabine: If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using gemcitabine.
Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis (AGEP) have been reported in association with gemcitabine treatment. Seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
PIL Section 4
You must contact your doctor immediately if you notice any of the following: A red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever (Acute Generalized Exanthematous Pustulosis (AGEP) (frequency not known).
Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing and dispensing this product, where possible. Copies of the correct PIL are available in the MHRA website.
The product is used in the treatment of non-small cell lung cancer (alone or together with cisplatin); pancreatic cancer; breast cancer (together with paclitaxel); ovarian cancer (together with carboplatin); bladder cancer (together with cisplatin).
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-hikma-farmaceutica-gemcitabine-2g-slash-52-dot-6ml-concentrate-for-solution-for-infusion-el-25-a-slash-43
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Sep 5, 2025
Issued at HKT 17:00
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